MAUDE Adverse Event Report: MAZOR ROBOTICS LTD MAZOR X SYSTEM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	TPL0059
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding a guidance system being used during a spinal procedure.It was reported that there was an issue during surgery.The surgery utilized a scan and plan workflow.The manufacturer representative performed a scan and prepared to plan the rest of the case.However, the anesthesiologist accidentally moved the patient during this time.It was realized that the scan had a portion of l2 cut off.Since the patient had been moved and part of l2 was cut, it was decided that a 2nd shot was needed.The representative moved the star marker north a few meters and took the shot, which successfully found the star marker.The representative inserted their usb, but the system did not give them the option to load a new scan.The manufacturer went to the 3define screen, but there was no populated scan.The representative then went to the mounting screen and the system prompted them with a message asking if they wished to remount.The representative selected no and moved forward.It then allowed them to import the 2nd exam.The star marker on this 2nd exam was successfully detected, so the representative planned the rest of the case.However, when the arm was sent to the first trajectory, l2, the arm went to the middle of l1 instead.The representative sent the arm to s5 and it arrived over the middle of l5.This was occurring despite the patient not being moved for the 2nd exam.The representative found that navigation was accurate, it was just the robot that was off.As a result, use of the system was abandoned.The procedure was delayed an hour or longer.There was no impact to the patient outcome, thought it was noted that the patient had extended anesthesia time due to the delay with the robot, and increased radiation due to two spins and another additional spin for the navigation system.The procedure was a l2-s1 posterior spinal fusion (psf).The procedure was completed with the navigation system.The inaccuracy was greater than 10mm.
Additional Manufacturer Narrative
A1, a2: patient initials and age/date of birth not available.A0908: inaccuracy a13: representative inserted their usb, but the system did not give them the option to load a new scan f1906: use of the system was abandoned f1908: delay to the procedure of one hour or longer f26: no impact to the patient h3, h6: no products were returned to medtronic for analysis.Codes b17, c20, and d15 are applicable.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: MAZOR X SYSTEM
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAZOR ROBOTICS LTD; 1 haeshel street. (building c); caesarea business park; caesarea hefa,il 30798 30; IS 3079830
• Manufacturer (Section G): MAZOR ROBOTICS LTD; 1 haeshel street. (building c); caesarea business park; caesarea hefa,il 30798 30; IS 3079830
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 24223143
• Report Number: 3005075696-2026-00038
• Device Sequence Number: 20914451
• Product Code: OLO
• UDI-Device Identifier: 07290109184098
• UDI-Public: (01)07290109184098(11)201110
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K230064
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TPL0059
• Device Catalogue Number: TPL0059
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/10/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 104 KG